P-094 Vedolizumab Adverse Events: Analysis of the FDA Adverse Event Reporting System

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Vedolizumab is a humanized monoclonal antibody that selectively antagonizes α4β7 gastrointestinal integrin receptors. It was approved by the United States Food and Drug Administration (FDA) in May 2014 for the treatments of moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). The most common adverse events in the GEMINI trials were nasopharyngitis, headache, arthralgia, upper respiratory tract infection, and cough and there was no difference from placebo. Serious adverse events occurred with equal frequency in vedolizumab and placebo patients.


We aimed to examine the adverse events reported to the FDA Adverse Event Reporting System (FAERS) among users of vedolizumab between May 2014 and December 2015. We calculated the proportion of adverse events by organ system, known as the system organ classification (SOC), and by specific adverse event, known as the preferred term. We aimed to examine if the most common adverse events reported to FAERS were consistent with those identified in the GEMINI trials.


There were 2631 adverse events reported. The most common adverse events by SOC were general disorders (19.3%), gastrointestinal disorders (16.4%), musculoskeletal and connective tissue disorders (10.3%), infections (9.3%), and skin disorders (7.7%). The most commonly reported preferred terms included arthralgia (3.6%), drug ineffective (2.3%), fatigue (2.5%), no adverse event (2.3%), headache (1.9%), rash (1.8%), nausea (1.8%), abdominal pain (1.7%), Crohn's disease (1.7%), and diarrhea (1.6%). The most commonly reported serious adverse events were Crohn's disease (2.5%), drug ineffective (2.2%), fatigue (1.9%), abdominal pain (1.7%), off label use (1.7%), pyrexia (1.7%), arthralgia (1.5%), headache (1.5%), nausea (1.5%) and ulcerative colitis (1.4%). Extra-intestinal serious adverse events included sepsis (n = 28), pulmonary embolism (n = 13), cerebral hemorrhage (n = 6), and lymphoma (n = 3). Deaths occurred in 34 patients. Causes of death that occurred in more than 1 patient included: sepsis, cardiac disorder, myocardial infarction, suicide and pneumonia. More adverse events associated with CD, UC or drug effectiveness were reported to FAERS than in the trials. Common serious adverse events observed in FAERS and the trials included death, sepsis, pulmonary embolism, cerebral hemorrhage, and suicide.


Although vedolizumab's mechanism of action is isolated to the integrin receptors of the gastrointestinal tract, extra-intestinal adverse events have been reported. Providers should acknowledge that vedolizumab may be associated with extra-intestinal adverse events until larger studies rigorously address these potential risks.

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